Pharmaceutical Quality Lead Role
This is an exceptional opportunity to assume a leadership position in a high-profile project, collaborating with experienced professionals and leveraging cutting-edge technologies.
As Pharmaceutical Quality Lead, you will oversee the quality release of Drug Product Intermediate and final stages, ensuring strict compliance with current regulations, including GMP Guidelines Directive 94/EC and FDA Code of Federal Regulations. You will work closely with the Specialist Quality Team to develop and implement Quality Management Systems and processes.
The ideal candidate will possess Qualified Person status, relevant experience acting as Named Qualified Person on a Manufacturing and Importation Authorisation (MIA), and proven expertise within the Pharmaceutical industry in QA/QC/Compliance roles. They will demonstrate excellent knowledge of regulatory frameworks, Quality IT systems, Lean/Continuous Improvement methodologies, and High Potency manufacturing/project management skills. A degree or post-graduate qualification in Science, Pharmacy, or equivalent is required.
Key Responsibilities:
* Lead the development and implementation of Quality Management Systems and processes.
* Ensure compliance with regulatory requirements, including GMP Guidelines Directive 94/EC and FDA Code of Federal Regulations.
* Collaborate with the Specialist Quality Team to oversee Quality IT systems and Lean/Continuous Improvement initiatives.
* Develop and maintain strong relationships with stakeholders, including customers, suppliers, and colleagues.
* Contribute to the development of business strategies and plans, aligning with company objectives.